The United States Food and Drug Administration estimates that approximately 1.3 million people in the United States are accidentally injured each year by medical therapy, 98,000 fatally. One study estimated the cost of treating patients suffering adverse drug effects to be nearly $4.5 billion annually. One type of adverse drug event, and one of the most tragic, is an error in administration, where the wrong drug or wrong dosage of the right drug is administered to a patient.
At least one study has shown that patients are in greatest danger of being exposed to a medication administration error during the first 48 hours of admission to a health care facility and within the first 48 hours after prescription of a new drug. These are precisely the times when staff and patients are both least likely to be familiar with the correct drugs, dosages, and treatment regimens appropriate for the individual. This highlights the need for fail-safe systems that reduce the possibilities of human error during drug administration.
Simple labeling of drug packages with printed indicia has progressed to coding of items as small as unit dose containers, or even single pills and capsules, with machine readable code, as seen for example, in U.S. Pat. No. 5,700,998 to Palti. This patent discloses a method of bar coding individual tablets and capsules. Such individual bar codes can be read by systems such as that seen in U.S. Pat. No. 4,857,713 to Brown.
A number of methods incorporate such coding as part of patient safety systems. For example, U.S. Pat. No. 4,857,713 to Brown discloses a system that both reads patient identification bands and medication unit dose bar codes, and interacts with a patient history file and a physician instruction file in a host computer, and a transaction file and an instruction file in a portable computer. The system compares the bar codes on the medication with the patient's identification, doctor's orders, and other database items.
However, all these systems pose two problems. First, a small bar code is often limited in the amount of information it can carry. Such coding of drugs traditionally identifies only limited information about the drug identity and the dosage. If additional patient or drug information is desired to be coded, a larger individualized bar code must be generated and attached to the medication in some fashion. Second, previous systems assume that a machine readable bar code is present on the unit dose packaging or on the medication itself, at all critical stages in the route of administration from prescription to patient. This has been difficult or impossible to achieve, until now, with a large class of medications, namely, those that are supplied in a liquid form, or in a powdered form for use with a diluent, where the medication must be drawn into a patient administration device. The prototypical example of this class is a liquid drug dispensed in a small ampule or vial, which must be opened, the contents of which are drawn into a syringe, and then administered to a patient. As an initial matter, the very small size of such ampules makes it difficult to bar code them. This small amount of space is further limited by the fact that the ampule labeling must not be covered by the bar code. Even if a bar code is attachable to an ampule, the small size limits most bar codes to very rudimentary information. Lastly, conventional bar codes placed on the ampule are not transferable, and therefore are detached from the medication as soon as the drug is dispensed into a syringe or other patient administration vehicle. This creates a potentially hazardous break in the chain of tracking of drugs from dispensing unit to patient administration.
Drugs are frequently opened or compounded in a pharmacy, drawn into syringes, and then transferred to a patient care unit. Alternatively, they are often prepared in a preparation area adjacent to a patient's room. Accordingly, there is a break in the chain of coding between pharmacy and eventual administration. The syringes or other patient administration devices may be placed into bar code labeled bags, or such similar carrier, but at all stages after the drug is placed into the syringe, there is an ever present danger that the drug will be separated from the labeling. Accordingly, there is a continuous danger of patient dosing mishaps.
The instant invention solves both of these shortcomings of previous bar code systems by providing a small bar code that can be custom printed to individual patients and their medications, and transferred from medication ampules or other small containers onto patient administration devices such as syringes or dose cups, thereby allowing medication to be accurately tracked and checked at any and all points between prescribing and administration.